FDA 510(k)

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E

K-Number: K241358 · 2024-06-13

ApplicantSun Pharmaceutical Industries, Inc.

Decision Date2024-06-13

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is the device name listed in this FDA 510(k) record. The listed applicant is Sun Pharmaceutical Industries, Inc.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K241358. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is Sun Pharmaceutical Industries, Inc.. The 510(k) number is K241358.

When did BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E receive FDA 510(k) clearance?

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E received FDA 510(k) clearance on 2024-06-13, under 510(k) number K241358.

Who is the listed applicant for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

The FDA 510(k) record lists Sun Pharmaceutical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

The FDA product code for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is GEX. This falls under the Gastroenterology category.

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Other records listing Sun Pharmaceutical Industries, Inc. as applicant

PMA P990019System, laser, photodynamic therapy

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.